Home / Recalls / Invuity, Inc. / Z-0007-2013

Z-0007-2013 Class II Terminated

Recalled by Invuity, Inc. — San Francisco, CA

Recall Details

Product Type: Devices
Report Date: October 10, 2012
Initiation Date: May 12, 2012
Termination Date: April 23, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 197 devices

Product Description

BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Reason for Recall

Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. It has not been distributed since March 2011 as the next generation product was introduced at that time.

Distribution Pattern

Nationwide Distribution including AR, GA, SC, CA, OR, UT, and WA.

Code Information

Catalog numbers: 1810000, 1811273, 1811873, 1810873, 18111073 All possible lot numbers: 8Fr: 09061802, 09070201, 09070201, 09101602, 09120701, 10022602, 10030801, 10060102; 10Fr: 09061801, 09070202, 09120702, 09101603, 10022603, 10030802, 10060905, 10060904, 10060103; 12Fr: 09052901, 09061201, 09120703, 09101604, 10022604, 10030803, 10060104.